from the isn't-that-nice dept

With the conclusion of the negotiations for the Trans Pacific Partnership (TPP) agreement now in place, there has been some ridiculous whining from the pharmaceutical industry which got almost everything it wanted in the agreement, but wasn't quite able to get a few things, including a 12 year patent-like exclusivity on biologics. And, because of that hissy fit, apparently, the USTR and its counterparts in Australia and Canada have agreed to help out Big Pharma in another arena. Jamie Love is reporting that this week there's a meeting at the WTO this week to explore granting a special exemption on patent rules for developing nations (i.e., those who often need drugs the most, while also being the least likely to be able to afford them). It's silly to enforce patents in these countries, because doing so would not only lead to almost no business at all, but (more importantly) because lots of people will die or, at the very least, suffer needlessly.

On Friday, 9 October 2015, Ambassador Punke met with representatives from 15 countries (including 5 Ambassadors) from the LDC Group. Ambassador Punke clearly indicated that the US could not agree on an indefinite exemption because certain stakeholders in the United States were quite upset with concessions made by USTR during the final stages of the Trans-Pacific Partnership (TPP). Informed sources noted that the US indicated that "the TPP did not deliver as expected on IP and so we are under a lot of pressure not to give in more on IP."

How far the pharma industry has come from the days when George Merck declared: "We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. The better we have remembered it, the larger they have been."

And, really, how do the folks who work at the USTR sleep at night knowing that they're doing this for no reason other than to help out the profits of a few giant companies at the expense of the public?

from the get-the-hell-out-of-the-way dept

Facebook's been taking a lot of heat lately for failing to understand (or pretending to fail to understand) how its Internet.org initiative spells trouble for net neutrality. As noted previously, Facebook's vision has been to deploy a "free" walled-garden service like AOL to developing nations. Critics have been dropping out of Internet.org, stating they don't like Facebook picking which companies get included in the walled garden. Things have gotten particularly heated in India, where neutrality advocates have made it very clear they think Facebook's vision hurts the open Internet long term.

Zuckerberg's response so far? You're hurting the poor if you don't like the way we're doing things, because a walled garden is better than no Internet at all. Of course that's a false choice: Facebook could offer subsidized access to the real Internet, it just wouldn't get pole position in delivering ads to billions of new users in dozens of developing nations. It's a mammoth advertising play dressed up as utterly-selfless altruism, with a dash of indignant at suggestions there's a better way.

Mozilla recently decided to jump into the conversation with a series of blog posts offering a much more intelligent, nuanced take on the problem with zero rated apps. In one post, Mozilla notes how if you let Facebook create a new definition of the Internet today, you're setting the stage for notable problems down the road:

"We understand the temptation to say “some content is better than no content,” choosing a lesser degree of inclusion over openness and equality of opportunity. But it shouldn’t be a binary choice; technology and innovation can create a better way, even though these new models may take some time to develop. Furthermore, choosing limited inclusion today, even though it offers short-term benefits, poses significant risk to the emergence of an open, competitive platform that will ultimately stifle inclusion and economic development."

That mirrors concerns by folks like Stanford Professor Susan Crawford, who have lambasted such models for "entrenching and amplifying existing inequalities and contributing to poverty of imagination." Mozilla notes there's plenty of ways to help fund Internet access to developing nations that doesn't involve building walls and cherry picking program participants. For example the company has struck a partnership with Orange to provide $40 Firefox OS smartphones with 6 free months of voice, text, and up to 500 MB per month of data. Another effort offers a small allotment of free data for watching an ad.

In short, there are options that don't turn the Internet into a glorified version of CompuServe. But rushing toward walled gardens again isn't just about today, it's about what these ideas mutate into over the longer haul. Mozilla Foundation Chair Mitchell Baker took this idea further in a second blog post:

"Selective zero-rating is unquestionably bad for the long term opportunities and inclusion for the people it is designed to serve. It pre-selects what’s available, directing people to where others want them to go. It is bad for economic inclusion. It is bad for the ability of new entrepreneurs to grow onto the global scale. It is bad for the long term health of the Internet. Zero-rating as practiced today is “selective zero-rating for a few apps and websites; exclusion for the rest of the Internet."

The correct answer is that all data is transmitted at the same price, whether that price is "zero" or anything else. This way, consumers pick the content they choose to access based on the quality of that content, not the financial power and business partnerships of the provider. This way, new entrepreneurs can still reach any and all users on the Internet, even if they are a few people working in a co-working space with no ability to subsidize data charges."

In other words, if Facebook really wants to help the poor, it can do so by using Internet.org to fund access to the "real Internet," not some bastardized version of the Internet that lets Facebook and select ISP partners play god. The conversation in India mirrors the conversation we've been having about systems like AT&T's Sponsored Data here in the States; opposition to zero rating is simply about getting massive gatekeepers out of the way and ensuring equal access to the purest version of the 'Net possible.

King said she is not concerned about the Development Agenda [at WIPO], but that there is still a need for greater balance for those who have IP rights.

In other words, she's not as worried, but she apparently feels that WIPO is somehow biased against patent and copyright holders. I suppose keeping out those evil Pirates out of WIPO was a step in the right direction, then....

from the also-he's-lying dept

We've written a few times about governments around the globe seeking to make use of lower-priced (and often more widely available) generic medicines for responding to serious diseases, rather than sticking with the more expensive name brand. Current international agreements, like TRIPs, allow countries to effectively "opt-out" of promises to respect other country's patent laws for the sake of supplying such medicine and, you know, saving lives. It's pretty clear that breaking the patent on these drugs is quite effective, driving costs down on a massive scale, making this part of healthcare much more cost-effective.

Of course, the pharma companies don't like this at all. So it should hardly be that big of a surprise that Senator Orrin Hatch directly tried to put pressure on Hillary Clinton and the Obama administration to stop efforts to promote more widespread use of generics in the developing world using these methods. The link above highlights that Hatch sent then Secretary of State Hillary Clinton a letter that suggested he's quite upset that the US-funded "Global Fund to Fight AIDS, Tuberculosis and Malaria" was training people in different countries to explore compulsory licenses of drugs or other ways to make use of generics.

Of course, if you just read Hatch's letter (embedded below), you'd be forgiven for being confused. In it, he claims to be outraged that the Global Fund is encouraging various countries to buy more expensive generics of "cheaper" brand name drugs. Huh? In what environment do generic drugs cost more than the brand name? Also, he appears to just be wrong. Part of the data that he based his complaint on comes from a presentation (embedded with the letter) from the Global Fund, in which they have a few graphs showing that (as you would expect if you were anyone but Orrin Hatch) the generic versions are, in fact, cheaper, which is obviously why they were recommending making use of the option.

So, even as Hatch's letter is full of bluster about misspending money, the details actually seem to suggest that they saved money.

In the letter, Hatch also claims that the presentation directly calls on countries to "disregard" the TRIPS Agreement. But, again, the attached presentation appears to tell the opposite story, with a specific call to seek solutions that comply with TRIPs.

Recipients must procure their products in accordance with national and international laws. The Global Fund encourages recipients to apply the flexibilities provided within national laws and in the World Trade Organization's Agreement on Trade-related Aspects of Intellectual Property rights (TRIPS)...

In other words, directly contrasting Hatch's claims, the Global Fund appeared to tell countries to comply with TRIPs, but (correctly) noted that there were some exceptions built within the law that allowed them to seek compulsory licensing and the use of much cheaper generics. Still, there may have been some behind-the-scenes maneuvering as well. As the IP-Watch report notes, soon after all of this, the executive director of the Global Fund, Michel Kazatchkine, resigned. The report suggests this was due to US pressure over Global Fund's daring effort to tell developing countries what their international agreements actually allow. Also: the replacement, Mark Dybul, is a US official, likely to make sure that the Global Fund works in the same manner as Hatch would like -- artificially keeping the big drug makers happily without competition and with artificially high profits, even as healthcare in the developing world might suffer.

Incredibly, Hatch actually seems to be arguing that by suggesting developing countries explore generics, it's putting people at risk because... well, there's a gap in the explanation, but it appears to be due to big pharma companies feeling they need such subsidies to make the drugs in the first place. From the letter:

By advocating for developing countries to disregard the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) through issuing compulsory licenses to gain access to Global Fund grants, we are abusing the system. Access to these products is vital to our success in fighting the war on HIV/AIDS and actions inconsistent with patent law such as these will only hinder our ability to work in partnership with the companies that have provided the intellectual property rights to develop generic versions of their products.

Got it? If you're a developing nation seeking to stem the AIDS epidemic by making AIDS drugs actually available to those with the disease, you are are actually decreasing the success of the war on AIDS because [something, something, something] big pharma will take their ball and go home. Of course, there's no actual evidence to support this, and tons of evidence that shows that developing countries who actually set a compulsory license on drugs related to critical diseases, actually do help deal with serious problems. There is no evidence that this suddenly scares companies into not making the drugs at all. They still make plenty of money in the developed world off of those drugs.

Just to summarize, though, an actual US Senator, Orrin Hatch argued that, by having the Global Fund advocate for better, cheaper generic medicines, as clearly allowed under international agreements, that the Global Fund is somehow paying more for medicines (they're not) and convincing big pharma to fail in the war against these diseases (they're not). It's no secret that politicians aren't always in sync with the truth, but this is significantly more blatant a misrepresentation than is normal.

from the oh-really-now? dept

There have been plenty of studies showing how -- especially in developing nations -- patents for pharmaceuticals serve to keep important drugs (which are cheap to manufacture) out of reach of the patients who need them most. In large part, because of this, various world bodies have accepted the idea that nations may decide to ignore patents in the interest of public health and safety. And that appears to work and be helpful. For example, we were just discussing how such generic copies were helpful in massively reducing the price of key drugs in India. And, no, this did not mean that the original manufacturer was unable to profit. This was on a drug where the company (Bayer) had made many times over its investment around the globe already, yet was still pricing the drug at over $5,000, while the generics were coming in at between $100 and $200.

There have been so many studies on this that you'd have to be either ignorant or deceitful to suggest that such a plan was a problem.

So I'm trying to figure out which adjective should apply to the USPTO, who recently gave a talk to a WIPO committee on the issue of patents and health, in which they argued that such efforts actually did more harm than good, and the way to keep people safe in developing countries was to increase patent protection:

There is no easy solution to these problems. Reducing patent protection is not likely to solve these thorny issues.... To the contrary, the lack of effective patent protection can be one of the many factors which prevent the appropriate medicines from reaching the neediest patients in DC and LDCs. Weakening the patent rights granted to pharmaceutical researchers and manufacturers in certain markets not only removes or reduces the incentive to develop new medicines, but also reduces the incentives for innovative medicine developers to invest in those countries and harness their innovation to solving the public health challenges that disproportionately affect developing countries, and are not being solved in other ways.

This statement is hogwash. First of all, there's nothing stopping these companies from profiting greatly in the developed world with these drugs, as they do already. And the idea that they wouldn't, say, invest in India if they could only get $100 per drug rather than $5,000... well, who cares? Considering how much more of these drugs they'd sell at those lower prices, there would still be plenty of profit to go around. Apparently, the folks at the USPTO have never learned a thing about price elasticity. Second, if a big pharma is too stupid to know how to provide drugs (which are relatively cheap to manufacture) at a reasonable cost for a profit, it seems pretty freaking natural that other companies are willing to step in and offer generics. So, really, why should anyone care if, say, Bayer decides to ignore India because it wants $5,000 for pills that others are willing to sell at $120? We're talking about the health and safety of the public, not Bayer.

Weakening patent protection for innovative medicines is not a productive approach to improving availability of health care, because many other factors other than patents more directly affect the availability of medicines.

The proof of the weakness of that argument is that although most medicines on the World Health Organization’s List of Essential Medicines are not protected by patents, their availability in many markets is still limited. This is particularly true in DC/LDCs. Many other factors affect the availability of all medicines, patented or not.

This is a nice bit of sleight of hand, confusing correlation with causation. No one says that a lack of patents means that such drugs are automatically made available in every market. But it takes a truly demented view of the world to take that fact and assume that such drugs would be more widely available if only those non-patented drugs were in fact covered by patent.

From there, the USPTO proposed a study to show how wonderful patents are in getting drugs to poor countries, to "restore balance to the discussion by evaluating the role of patent protection in providing incentives for research and development...." Funny how they were just talking about drugs that were off-patent not being available... but now they ignore that and it's all about new drug development. But, more seriously, I find it absolutely hilarious that the USPTO wants to talk about "restoring balance." This is an organization that has always pushed for "more patents" at pretty much any cost. The whole software industry is facing a massive crisis of gridlocked development over bogus patents. If we're going to start "restoring balance" to the patent system, let's start at home.

This kind of stuff is really sickening, because it's basically the USPTO saying that poor people around the globe should suffer and die if helping them doesn't produce enough profits for big pharmaceutical conglomerates. I don't know how people taking that position can sleep at night.

from the hypocrites dept

We've discussed many, many times how the US and other developed nations have been relying on extreme secrecy in crafting new intellectual property agreements, such as ACTA and TPP. They continue to insist that no one else should be in the room when they discuss these important laws. So, what happens when some poorer developing nations want to get together to discuss how developing nations might create better intellectual property laws that match their own specific needs? You guessed it. The big developing nations freak out and demand to be in the room. Apparently, the developed nations only think things should be secret for their own intellectual property discussions.

This all happened recently at WIPO, concerning the Development Agenda. As a bit of background, over the past few years, WIPO has finally come around to realizing that a single strict intellectual property regime around the world doesn't make much sense. Over the last decade, the amount of evidence showing how developing nations are seriously harmed by strict intellectual property laws is overwhelming and, at this point, incontrovertible. With that in mind, the Development Agenda within WIPO has grown, allowing various developing nations to really seek out alternative views on intellectual property. In fact, this is why ACTA and TPP are being done outside of WIPO, despite it being the natural place for such agreements: because the US (mainly), and some others like Japan, didn't want to let the developing nations into the conversation.

And yet, when the Development Agenda tried to have some private discussions on "enhancing cooperation" on intellectual property issues among developing nations... the developed nations threw something of a hissy fit, and effectively derailed the meetings by demanding to be there. The end result was that the meetings were suspended:

In the project, two inter-regional meetings were planned among developing countries and LDCs, and two annual conferences with the full WIPO membership. According to sources, the two inter-regional meetings would have been closed meetings only allowing members from developing countries and LDCs and that was challenged, in particular by developed countries.

Some concessions were made so that only the first inter-regional meeting would have been closed and the second one would be open to developed countries but only with an observer status, with one conference open to the whole WIPO membership, according to sources. Some developed countries argued that no meeting should be restricted to only some members as some developing countries purported the opposite opinion, saying that a closed meeting would constitute the first step of South-South collaboration, sources said.

No consensus seemed reachable and Egypt asked for a vote to adopt the project, backed up by India and South Africa. Matters got only worse when a developed country member asked for a secret ballot vote, which gave way to a discussion on the WIPO rules of procedures and the difficulty to organise a secret ballot vote this late into the evening and the meeting, sources said.

Egypt finally asked for a suspension of the meeting, backed up by India, according to a source. The vice-chair of the meeting, Garikai Kashitiku, first secretary of the permanent mission of Zimbabwe, suspended the meeting.

While I tend to think that all such discussions should be open, I find it astoundingly hypocritical of the "developed nations" to insist on keeping their own discussions entirely secret (and even taking them out of WIPO to keep them secret), and then to claim that these discussions need to involve them.

from the this-is-important dept

We've discussed a few times how the current patent regime is causing massive problems in poor and developing countries around the world, where simple and available medications would save many, many lives (which would also help those economies). Tragically, in our over-active belief in patents, governments in the developed world have argued, completely unconvincingly, that drug companies have to price drugs at ridiculous prices via monopolies, even in developing nations where people can't afford them, in order to make it worthwhile to invest in the drug. There is little actual evidence to support this claim, and in fact, basic common sense suggests there's little to support this. A few years back, Canada tried to deal with this issue by passing a law that would allow generic drug manufacturers to produce cheaper drugs for a specific list of developing nations. However, the process was full of red-tape, and involved negotiating with the patent holder (potentially multiple times). In the end, despite being in place for years, the law was actually used only once.

Some politicians in Canada have been pushing for a revamp of the law to make it much easier to get those generic drugs into developing nations, and thankfully the Canadian House has approved the bill. The Senate still has to vote on it, and it appears there are concerns about the likelihood of it getting approved there, but it's still notable that a drug bill aimed at getting around patents and helping developing nations even got this far....

from the but-is-it-enough-to-matter? dept

Vivek Wadhwa has an interesting post at TechCrunch, pointing out that much of the world beyond the US, Europe and BRIC (Brazil, Russia, India, China) are effectively a patent free zone. Even if many of these places do have patent laws, very few companies find it worth the trouble to file for patents in those places -- and, technically, that means that anyone producing products in those areas can legally copy from the patents filed elsewhere.

Take the iPhone as an example: it has over 1000 patents; yet Apple does not apply for patent protection in countries like Peru, Ghana, or Ecuador, or, for that matter, in most of the developing world. So entrepreneurs could use these patent filings to gain information to make an iPhone-like device that solves the unique problems of these countries. Apple has so far received 3287 U.S.-issued patents and has 1767 applications pending: a total of 5054 (for all of its products). Yet it has filed for only about 300 patents in China and has been issued 19. In India, it has filed only 38 patent applications and has received four patents. In Mexico it has filed for 109 and received 59 patents. So even India, China, and Mexico are wide-open fields.

Of course, if you were to make an iPhone in Peru or Ghana, you wouldn't be able to export it to the US, as then it would again be considered infringing. So, the market size for a "legal" knockoff iPhone might be pretty limited. On top of that, there's a pretty good reason why companies like Apple don't bother filing for patents in these places: the economy and the local infrastructure really aren't advanced enough to make a difference. So, even if these are "patent free zones," the lack of other institutions to make innovation and economic growth important mean that this really doesn't matter very much.

Still, it does raise some questions about if there are "opportunities" within those patent free zones. Certainly, it would not be a historical anomaly to see part of the patent free zone step up and use that fact to help it industrialize. As we've seen in the past, countries like Switzerland and the Netherlands used the fact that they were patent free zones for parts of the 19th century to speed up their industrialization process. But, of course, as we saw with both of those, once their industries got big enough, foreign competitors started to freak out and put tremendous pressure on those countries to put in place patent laws.

However, there are some areas where the ability to ignore patents could be quite helpful, especially for areas that could massively help those developing nations:

Take desalination, in which GE is one of the largest players. GE has spent more than $4.1 billion to acquire its part of the desalination business. Yet a decade after commencing, they're still nowhere close to making desalination affordable and sustainable. GE's progress depends on the patents it owns. As of 2009, GE invented 47 of the 832 U.S. patents in this field--just 5.6%, or a little more than one-twentieth. Consider the progress that GE could make if it could also use any of the patents that it doesn't own--of which there are many.

How much better would the world be if we didn't have to spend another ten years waiting for innovation in the desalination space? There are many areas of collaboration in the Patent-Free Zone that could produce innovative solutions for our world. Solar power, electric cars, mobile technologies for the poor, disease eradication, medical devices, food processing--to name a few. Wouldn't it be ironic if poor countries ended up solving the problems of the rich?

from the it's-possible dept

A few folks sent in Andy Oram's recent blog post that noted how countries like India, China and Brazil were gaining more power on the international diplomatic stage, and that could mean a pushback against more draconian intellectual property attempts. Brazil, China and India have all realized that, as developing nations, they often benefit greatly from reduced intellectual property regimes:

As I understand the argument, the institutions responsible for passing new rules respond to the most powerful countries. The US and Europe are on the decline in these organizations. All the countries that benefit from looser IP regimes--China, India, Brazil--are growing in economic strength and are finding themselves in more and more seats at the tables of the world's closed economic institutions. For just one concrete example, look at the shift of responsibility in recent years from the G-7 to the G-20. The G-7 is a familiar set of countries that were powerful from the 1950s through the 1970s. The G-20 is truly diverse, bringing in strong economies from around the world (but still just the ones with some international economic clout).

I'll believe it when I see it. While it is true that those other countries have a seat at the table, it's still the lobbyists from the US and Europe that seem to be dictating the agenda. In recent years, we've definitely pushed increasingly draconian IP laws on those countries. So until we see more serious pushback (and Brazil is really the only major country I can remember that has been proactive on that front -- India and China have appeared more willing to claim that they'll move toward US-style IP rules) it's difficult to believe this is really happening just yet.

from the probably-not dept

Joseph Franklin has written about how a group of universities have agreed to some basic principles (pdf) about providing drugs to developing nations at reasonable costs (or even free) in the interest of better global healthcare. However, Franklin wonders how well this will work in practice, and why it should only apply to developing nations, and not domestically as well. It's an interesting question, made more complicated by the fact that many drugs have their research started at universities -- frequently backed by government money -- but are later taken over by pharmaceutical companies who have no interest in such principles. I tend to think that such "principles" are nice to speak about, but are rarely effective in actually creating change. I would think that a much stronger argument is showing the economic benefits in keeping people alive. If you could rid some developing nations of certain diseases, you'd be able to open up vast new markets for other industries. Hell, imagine if you could get companies in other industries (food, clothing, transportation, etc.) to pay for drugs for the poor in developing nations, knowing that keeping them healthy will help those nations build their economy so they can start purchasing the same food, clothing and transportation...